NCT01566084

Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

Detailed description

The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Slow sodium tablets	The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.
OTHER	placebo	Placebo tablets are administered to maintain the low sodium condition.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-03-29
• Last updated: 2016-01-07
• Results posted: 2014-06-20

Locations

1 site across 1 country: United States